78/100 · Elevated
Manufactured by Melinta Therapeutics, LLC
Metoprolol Succinate Adverse Events: High Serious Reaction Rate
159,895 FDA adverse event reports analyzed
Last updated: 2026-05-12
METOPROLOL SUCCINATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Melinta Therapeutics, LLC. Based on analysis of 159,895 FDA adverse event reports, METOPROLOL SUCCINATE has a safety score of 78 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for METOPROLOL SUCCINATE include FATIGUE, DIARRHOEA, NAUSEA, DYSPNOEA, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for METOPROLOL SUCCINATE.
Metoprolol Succinate has a safety concern score of 78 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 159,895 adverse event reports for this medication, which is primarily manufactured by Melinta Therapeutics, Llc.
The most commonly reported adverse events include Fatigue, Diarrhoea, Nausea. Of classified reports, 63.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High incidence of serious reactions such as death, myocardial infarction, and renal failure.
Common gastrointestinal issues like nausea, diarrhea, and abdominal pain. Significant drug interactions and dose-related issues reported.
Patients taking Metoprolol Succinate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Caution is advised with drug interactions, and patients should be monitored for dose-related issues, including potential for hypotension and bradycardia. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Metoprolol Succinate received a safety concern score of 78/100 (high concern). This is based on a 63.2% serious event ratio across 81,916 classified reports. The score accounts for 159,895 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 42,748, Male: 33,657, Unknown: 45. The most frequently reported age groups are age 73 (1,594 reports), age 71 (1,587 reports), age 68 (1,552 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 81,916 classified reports for METOPROLOL SUCCINATE:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Caution is advised with drug interactions, and patients should be monitored for dose-related issues, including potential for hypotension and bradycardia.
If you are taking Metoprolol Succinate, here are important things to know. The most commonly reported side effects include fatigue, diarrhoea, nausea, dyspnoea, drug ineffective. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor patients for serious adverse events, particularly cardiovascular issues and renal failure. Be aware of potential drug interactions and adjust dosing accordingly. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor Metoprolol Succinate for safety, and updates will be provided as necessary.
The FDA has received approximately 159,895 adverse event reports associated with Metoprolol Succinate. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Metoprolol Succinate include Fatigue, Diarrhoea, Nausea, Dyspnoea, Drug Ineffective. By volume, the top reported reactions are: Fatigue (6,104 reports), Diarrhoea (4,973 reports), Nausea (4,768 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Metoprolol Succinate.
Out of 81,916 classified reports, 51,736 (63.2%) were classified as serious and 30,180 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Metoprolol Succinate break down by patient sex as follows: Female: 42,748, Male: 33,657, Unknown: 45. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Metoprolol Succinate adverse events are: age 73: 1,594 reports, age 71: 1,587 reports, age 68: 1,552 reports, age 74: 1,544 reports, age 72: 1,540 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Metoprolol Succinate adverse event reports is Melinta Therapeutics, Llc. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Metoprolol Succinate include: Off Label Use, Dizziness, Headache, Death, Asthenia. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Metoprolol Succinate to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Metoprolol Succinate has a safety concern score of 78 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. High incidence of serious reactions such as death, myocardial infarction, and renal failure.
Key safety signals identified in Metoprolol Succinate's adverse event data include: High number of serious adverse events (51,736 out of 81,916 total outcomes, 63.2%). Common gastrointestinal symptoms (fatigue, nausea, diarrhea, etc.). Multiple reports of cardiovascular issues (myocardial infarction, atrial fibrillation, heart failure). These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Caution is advised with drug interactions, and patients should be monitored for dose-related issues, including potential for hypotension and bradycardia. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Metoprolol Succinate.
Monitor patients for serious adverse events, particularly cardiovascular issues and renal failure. Be aware of potential drug interactions and adjust dosing accordingly.
Metoprolol Succinate has 159,895 adverse event reports on file with the FDA. Common gastrointestinal issues like nausea, diarrhea, and abdominal pain. The volume of reports for Metoprolol Succinate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Metoprolol Succinate for safety, and updates will be provided as necessary. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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